A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

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An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Rising PSA, as defined by increasing levels on at least two consecutive assessments

ECOG performance status 0 or 1

Adequate hematologic function

Adequate liver and renal function

Able to swallow and retain oral medication.

Exclusion Criteria:

Received prior chemotherapy for HRPC.

Concurrent therapy for the treatment of prostate cancer.

Clinical signs or symptoms of CNS metastases

Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.

Active secondary malignancy or history of other malignancy within the last 5 years.